Drug that delays onset of type 1 diabetes approved in England and Wales | Diabetes
The world’s first drug to delay the onset of type 1 diabetes is to be made available on the NHS in England and Wales in the biggest breakthrough in tackling the disease in more than a century.
Millions of people worldwide have type 1 diabetes, which usually occurs in childhood or adolescence and occurs when the pancreas produces little or no insulin. Insulin is a hormone the body uses to allow glucose to enter cells to produce energy.
The immunotherapy, teplizumab, does not cure type 1 diabetes but delays its onset by up to three years, according to the National Institute for Health and Care Excellence (Nice), which gave the drug the green light on Tuesday.
His arrival marks a major step forward. The therapy gives people considered at high risk for symptomatic type 1 (stage 3) diabetes a chance to delay the onset of the disease for the first time in history.
By delaying onset, people will benefit from years of extra time before facing the heavy demands of lifelong diabetes management. Children and teens in particular will have more time to reach important developmental milestones before this point.
Nice has approved the drug for use in adults and children aged eight and over with early, pre-symptomatic type 1 diabetes (stage 2), allowing them to live more normal lives for longer.
Insulin, the only other treatment for the disease, was discovered 105 years ago and does not change the course of the disease. It simply replaces what the patients are missing.
Research director of the charity Diabetes UK, Dr. “Today’s landmark approval of teplizumab marks the beginning of a new era in the treatment of type 1 diabetes,” said Elizabeth Robertson, MD. “For the first time in 100 years, we are moving beyond insulin with a drug that targets the root cause of disease.
“This is an extraordinary moment for celebration in the type 1 diabetes community and represents a transition towards a future where type 1 diabetes can be completely prevented.”
Teplizumab, also known as Tzield and manufactured by Sanofi, will offer people in the early stages of type 1 diabetes valuable time to prepare, as well as being “free from the relentless demands” of managing the condition with insulin, Robertson said.
“Early detection of type 1 diabetes, before symptoms appear, is key to reaping these benefits, and our focus now is to ensure fair and equitable access for all who qualify.”
Teplizumab trains the immune system to stop attacking pancreatic cells. It is given by intravenous drip once a day (taking about 30 minutes) for 14 consecutive days.
The dose starts low and increases gradually. The treatment ends after the 14-day cure is completed.
Karen Addington, chief executive of diabetes charity Breakthrough T1D, said the drug’s approval was an “incredible moment” for the type 1 community. “For the first time, we have an immunotherapy that can delay the onset of symptomatic type 1 diabetes.
“If it was your child or loved one, you would want to do everything possible to give them more years without the daily burden of managing this relentless condition. We now have a treatment that can help make that possible.”
The Guardian understands Sanofi has signed a commercial agreement with NHS England; This means teplizumab will be made available to the NHS at a confidential discounted price.
Helen Knight, director of drug evaluation at Nice, said the decision to approve the drug was rigorous, transparent and based on the best available evidence, striking a balance between clinical benefit and value for taxpayers.
“This is a really exciting proposition. For the first time, we have a treatment that could give people diagnosed in the early stage of type 1 diabetes valuable extra time before they need to meet the full demands of the condition.”
